Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Skin Pigment Clinical Trial

Official title:

Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144541
• Other study ID #: i23-09_Fitz_Skin
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Integrative Skin Science and Research
• Contact: Raja Sivamani, MD
• Phone: 916-524-1216
• Email: raja.sivamani[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements.

Description:

The Fitzpatrick scale is a numerical classification for human skin color developed in 1975 as a way to estimate the response of different types of skin to UV light. It is used by dermatologists to classify skin tone and assess the risk of skin cancer. The Fitzpatrick scale encompasses six gradings, from I to VI. However, this does not include all skin tones, as there are significantly more not encompassed within the scale. The aim of this study is to incorporate objective measurements when identifying a patient's Fitzpatrick skin type.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and females that are 18 years of age and older
• Subjects with all Fitzpatrick skin types I-VI One-third of subjects will be Fitzpatrick I or II skin types, one-third of subjects will be III or IV, and one-third will have V and VI.

Exclusion Criteria:

• Individuals who are pregnant or breastfeeding.
• Prisoners
• Adults unable to consent
• Individuals with open wounds on the nondominant upper inner arm
• Individuals with fibrotic skin disease or other skin conditions or hair growth on the nondominant upper inner arm that could affect skin measurements in the opinion of the investigator
• Individuals with tattoos that cover the site on the nondominant upper inner arm
• Individuals with post-inflammatory hypopigmentation or hyperpigmentation
• Individuals with vitiligo
• Individuals who have used self-tanning products or tanning beds in the last two weeks.

Related Conditions & MeSH terms

• Pigmentation Disorders
• Skin Pigment

Intervention

Other:
• Survey administration for Fitzpatrick skin type
Survey administration for Fitzpatrick skin type

Device:
• Measurement of ITA based on SkinColorCatch instrument
Measurement of ITA based on SkinColorCatch instrument

Locations

Country	Name	City	State
United States	Integrative Skin Science & Research	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Integrative Skin Science and Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type	Correlation of ITA by the use of SkinColorCatch (Delfin) compared to the Fitzpatrick skin scale as determined by the patients' responses to validated questionnaire.; The higher the ITA, the lighter the skin. ITA skin color types are classified into six groups, from Very Light to Dark skin.	One time - collected for up to 1 year for the entire study
Secondary	Assess Fitzpatrick Skin type based on validated questionnaire	Questionnaire about sun sensitivity and tanning will be administered to calculate the Fitzpatrick skin types	One time - collected for up to 1 year for the entire study
Secondary	Sun protection habit use	Quantification of sun protection habits based on survey question asking their typical use of sun protection	One time - collected for up to 1 year for the entire study